drugset / Trial / NCT02217020

Neoadjuvant FOLFOXIRI Chemotherapy Alone for Locally Advanced Rectal Cancer

NCT02217020 ↗

Phase 2 Completed 100 enrolled Sun Yat-sen University
NaSingle-groupOpen-labelTreatment

Summary

The standard treatment for stage 2/3 rectal cancer is neoadjuvant 5-Fu based chemoradiation. However, preoperative radiation cause kinds of adverse events, some were irreversible. And the survival benefit was not obvious. Whether chemotherapy alone is effective enough in treating rectal cancer is not yet known. Here, the investigators chose all the three active cytotoxic agents (5-FU, Oxaliplatin, Irinotecan) as the neoadjuvant treatment regimen (FOLFOXIRI). The purpose of the study is to evaluate the efficacy of FOLFOXIRI as neoadjuvant regimen in treating patients with locally advanced rectal cancer.

Timeline

Start
2014-08-15
Primary completion
2016-09-15
Completion
2017-08-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Irinotecan Small molecule 165 mg/m2 —
Subject Leucovorin Small molecule 200 mg/m2 —
Subject Oxaliplatin Small molecule 85 mg/m2 —
Subject fluorouracil Small molecule 2800 mg/m2 —

Indications